SDT
- Product code
- SDT
- Device name
- Intra-Pulmonary Percussive Vibration (Ipv) Devices
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.5665
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 3
FDA classification definition
It is intended to mobilize mucus using vibration and/or pressure delivered through a mouthpiece into the airways.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K241091 | 2024-12-23 | Inogen, Inc. | SIMEOX 200 Airway Clearance Device |
Official FDA classification page: SDT
Classification and pathway per current FDA publications. Data from openFDA (CC0).